SIST EN ISO 16212:2017/A1:2023 PDF

Overview

EN ISO 16212:2017/A1:2022 is the CEN-endorsed amendment to ISO 16212:2017, an international standard for cosmetics microbiology addressing the enumeration of yeast and mould in cosmetic products. Amendment 1 (A1) introduces a new medium formulation - the Modified Eugon LT liquid broth - and its preparation details to support reliable yeast and mould testing in cosmetic quality control laboratories.

Key topics and technical requirements

• New Annex A subclause (A.4): Adds the composition and preparation procedure for the Modified Eugon LT liquid broth.
• Medium composition (per 1 000 ml water):
  • Pancreatic digest of casein: 15 g
  • Papain digest of soybean meal: 5 g
  • Sodium chloride: 4 g
  • L-cystine: 0.7 g
  • Sodium sulphite: 0.2 g
  • Glucose: 5.5 g
  • Egg lecithin: 1 g
  • Polysorbate 80: 15 g
  • Sodium lauryl ether sulfate: 1.56 g
• Preparation steps:
  • Dissolve polysorbate 80 and egg lecithin successively into boiling water until fully dissolved.
  • Dissolve remaining components by mixing while heating.
  • Dispense into suitable containers and sterilize in an autoclave at 121 °C for 15 minutes.
  • Mix while still hot to redissolve any settled substances.
  • After sterilization, the medium pH at room temperature shall be 7.0 ± 0.2.

Note: This amendment modifies EN ISO 16212:2017 as adopted by CEN; full procedural and validation details remain in the base standard and should be consulted for complete test methods and quality requirements.

Applications and users

• Who uses this standard:
  • Cosmetic manufacturers and formulators
  • Quality control and microbiology laboratories
  • Regulatory bodies and conformity assessors
  • Contract testing labs and suppliers of culture media
• Practical uses:
  • Routine microbial quality control to enumerate yeast and mould in finished cosmetic products and raw materials
  • Shelf-life and stability testing where fungal contamination is a concern
  • Method standardization across laboratories to ensure comparability of yeast/mould counts
  • Development and validation of in-house test procedures using the specified medium

Related standards and context

• EN ISO 16212:2017 (base standard) - method for enumeration of yeast and mould in cosmetics.
• Prepared by ISO/TC 217 and CEN/TC 392 under the Vienna Agreement; consult national adoption documents for implementation dates and any national guidance.

For compliance and laboratory implementation, obtain the full EN ISO 16212:2017 and Amendment 1 documents to ensure adherence to all method, validation and reporting requirements.